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存在试验期间事件的外部对照试验：双重稳健综合敏感性分析AI 解读

Externally controlled trials are crucial in clinical development when randomized controlled trials are unethical or impractical. These trials consist of a full treatment arm with the experimental treatment and a full external control arm. However, they present significant challenges in learning the treatment effect due to the lack of randomization and a parallel control group. Besides baseline incomparability, outcome mean non-exchangeability, caused by differences in…

真实效应还是偏差？用未测混杂定量敏感性分析评估真实世界证据AI 解读

The assumption of no unmeasured confounders is a critical but unverifiable assumption required for causal inference yet quantitative sensitivity analyses to assess robustness of real-world evidence remains underutilized. The lack of use is likely in part due to complexity of implementation and often specific and restrictive data requirements required for application of each method. With the advent of sensitivity analyses methods that are broadly applicable in that they do…